Rheopheresis for Dry Age-Related Macular Degeneration (AMD ...

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Adverse events/side effects: Adverse events during Rheopheresis: Defined as any unexpected or symptomatic event, which has a possible, probable or definite causa relationship with the Rheopheresis treatment. If events are reported after the treatment, specific time intervals have to be defined for particular events/problems before such events are shown in the classified RheoNet report. If there is more than one adverse event/side effect at the same time leading to a discontinuation of the treatment, the discontinuation shall be only accounted to the adverse event of highest clinical relevance. Adverse events after Rheopheresis: - severe hypotension/syncope within 24 hrs after Rheopheresis, - retinal bleeding withn 14 days after Rheopheresis Vascular access problem: Any problem occurring with the vascular access for Rheopheresis, if a treatment is really performed (e.g. difficult needle insertion, flow problem, dislocation of needle, several attempts of needle insertion, collapsed vein etc.). Hematoma/bleeding at the needle insertion is accounted as adverse event/side effect. Technical problem: Reporting to RheoNet – SOP Categories of Adverse Events / Side Effects / Problems Defined as reports on malfunction of the therapy machine or material (filters, tubes etc.) including also handling problems of personnel.
Reporting to RheoNet – SOP lasses of adverse events/side effects, vascular access problems, technical problems Centers only report / only ARI classifies! Class I All side effects/ problems, which were reported with the single Rheopheresis treatment. Class II All reported side effects/problems of class I, which were followed by an intervention (e.g. infusion o saline etc.) and/or temporary break and/or discontinuation of the Rheopheresis treatment. Class III All reported side effects/problems of class II, which necessitated discontinuation of the Rheopheresis treatment (no multiple references, discontinuation was assigned to one side effect/problem). Discontinuation of Rheopheresis Discontinuation of Rheopheresis is registered, if the treated plasma volume was 70% or lower of the 100% plasma volume target. Discontinuation due to side effects is always registered as discontinuation, if the extracorporeal circuit had started independent of the treated plasma volume. Discontinuation due to problems with venous access or technical problems is registered as discontinuation, if the treated plasma volume was already 500 ml or more. If the treated plasma volume was below 500 ml, the report must be evaluated with the individual case including discussion with the therapy center.
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